OBJECTIVE:To further perfect our Pharmaceutical Administration Law of PRC.METHODS:Contractive methods were used to analyze comparatively the legal liabilities in US FDCA and Pharmaceutical Administration Law of PRC with regard to awarding system for reporters,penalty terms and the disposition of the confiscated drugs.RESULTS&CON?CLUSION:Compared with the PRC Pharmaceutical Administration Law,the US FDCA is more comprehensive and more consummate.We should follow the legislative spirit in FDCA and take it as a reference to improve our Pharmaceutical Ad?ministration Law.

OBJECTIVE:To provide references for the establishment of drug recall system in China.METHODS: The drug recall system in U.S.A. was introduced so as to get some enlightenment for the drug safety in China.RESULTS & CONCLUSION: We could use the drug recall system in U.S.A. for references to improve our law criterion system and carry out drug recall system on a large scale.

Renal function is closely associated with the risk of mortality ,cardiovascular events ,and progression to end stage of renal disease for patients with chronic kidney disease ( CKD ).Equations for estimated glomerular filtration rate ( GFR) based on serum creatinine or Cystatin C are frequently used in clinical evaluation of renal function.Although renal function can be more accurately assessed due to improvement in equations for estimated GFR ,it is difficult to overcome the inherent defect of creatinine based GFR estimation.Abundant ,evidence showed that Cystatin C based GFR estimation presented higher accuracy of prognosis assessment in CKD patients than creatinine based GFR estimation ,thus reduce the unnecessary nephrologist referral and measurements for low risk patients ,and also guarantee the timely recognization and intervention for high risk patients.This article deeply reviewed the role of serum creatinine or Cystatin C played in CKD diagnosis and prognosis assessment.

Objective:To explore the chemical-biological evaluation pattern for the quality control and evaluation of Chinese materia medica solid preparations( CMMSP) according with the characteristics of Chinese traditional medicines. Methods:Lonicera granule as the model drug, the bacteria sensitive tests [minimal inhibitory concentration (MIC) and minimal bactericidal concentration(MBC)] were applied to study the antimicrobial effect of Lonicera extract on 4 kinds of standard strains ( Staphylococcus aureus, Streptococcus pneumoni-ae, Escherichia coli and Pseudomonas aeruginosa). The standard curves of the relationship between the anti-bacterial ring diameter for sensitive bacterial and the concentration of Lonicera extracts were established, and the biological potency of Lonicera granule from differ-ent manufacturers was calculated and compared with the result of the HPLC method ( measured by chlorogenic acid) . Results:The anti-microbial test showed that Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli and Pseudomonas aeruginosa were susceptible to Lonicera, and the antibacterial circle edge for Staphylococcus aureus was clear with higher sensitivity. There was a good linear relation-ship between the logarithmic dose and the response effect when the concentration of Lonicera was within the range of 0. 014 2-0. 068 0 g· ml-1(r=0.990 9). Conclusion:As a quality control method for Lonicera and Lonicera granules, the bioassay is feasible, which can ef-fectively cooperate with the traditional test method for the quality control of Lonicera and its preparations.

Objective:To establish an HPLC method for the simultaneous determination of 7 flavonoids in Fengliaochangweikang capsules, and optimize the extraction process for total flavones. Methods:The extraction process was optimized by orthogonal test. The analysis was performed on a Waters RP18 column (250 mm × 4. 6 mm,5 μm). The mobile phase A was methanol-water (80 :20) and the mobile phase B was methanol-0. 2% formic acid (17 :83) with gradient elution. The flow rate was 1. 0 ml·min-1 and the column temperature was 35℃. The detection wavelength changed as follows:0-27 min,λ1 = 260 nm;27-60min,λ2 = 360 nm. Results:The 7 flavonoids obtained the baseline separation in 60 min, and the linear correlation coefficients were all above or equal to 0. 9900. The average recovery was 95. 95%-97. 84% and RSD was 0. 81%-1. 33%. The optimum extraction conditions were as follows:solid-liquid ratio was 1 :15,AB-8 macroporous adsorption resin was used, the ultrasonic extraction time was 30min, and the ethanol concentration was 60%. Conclusion:The established method has the advantages of simple operation, high precision and good repeatability,which shows certain guiding significance for the quality control and detection of Fengliaochangweikang capsules.

Among the 7 artificial paraoxon antigens studied, we found that paraoxon-tetanus toxoid has the best immunologic effect. All the 14 immunized rabbits with paraoxon-tetanus toxoid survived after a challenge of 1LD of paraoxon injected intramuscularly. The effective prophylactic period was 1 month. There were more than 10 units of antitetanus antitoxin in 1 ml antiserum of the immunized rabbit.

Quantitative immunoassay technique is the common method of quantitative detection in clinical laboratory. Several important branches of quantitative immunoassay were formed by changing the tracer or the Antigen-antibody complex separation method, including radioimmunoassay, fluorescent immunoassay, enzyme immunoassay, chemiluminescence, colloidal gold, immuno-turbidimetric analysis and homogeneous immunoassay. Different immunoassay techniques have their own characteristics, also apply to different detecting conditions in clinic. This paper reviewed several common kinds of quantitative immunoassay technology, and discussed both their advantages and disadvantages, which provide reference for the application and development of clinical testing technology.

Objective To explore the treatment of irritable bowel syndrome, massage combined with microecological modulator therapy. Methods For 40 cases of irritable bowel syndrome patients using micro ecological regulator treatment, and classified as the control group, the other 40 patients used massage combined with microecological regulating agent treatment, and to the observation group, two groups of patients were in our hospital from March 2015 to January 2017. Results No significant difference between the two groups of patients in the treatment of the bacteria, after the number of packet treatmentintestinal aureus two groups had no significant difference, other bacteria were the observation group of patients obviously improved, improved the difference was significant(P<0.05). The total effective rate in observation group was 97.5%, only 75% of the control group, the observation group were significantly higher. Conclusion The clinical study of massage combined with microecological preparation in treatment of irritable bowel syndrome, the treatment is simple compared to micro ecological regulator, has certain advantages, can improve clinical symptoms of patients. At the same time, improve the therapeutic effect, so it is worthy of clinical use of priority.

OBJECTIVE: To discuss the limitation of the current TRIPS due to local protection and to seek for a balance between drug patent protection and public health.METHODS: The related clauses in TRIPS in terms of protection on drug patent and public health were introduced,and Nordhaus' model was used to analyze the conflict between drug patent protection and public health.RESULTS: The area with minimum level of drug patent protection can't be enlarged infinitely geographically.CONCLUSIONS: Preferential policies should be given to the developing countries to secure the public health while strengthening the drug patent protection gradually.

Objective To investigate the effects of panax notoginseng saponins(PNS) on the expression of IL-10 and TNF-α in the brain after focal cerebral ischemia-reperfusion injury in rats,and the mechanism was explored.Methods 30 male adult Sprague-Dawley rats were randomly divided into sham-operation group,ischemia-reperfusion group and PNS treatment group,10 rats in each group.The middle cerebral artery occlusion(MCAO) was established with ischemia-reperfusion group.The rats received continuous gastric lavage for 4 weeks,who were observed for 3 days and then killed to the detect the expression of IL-10 and TNF-αin ischemic region by ELISA,immunohistochemistry and RT-PCR.The behavioral ability score in rats were tested.Results Compared with the sham-operation group and ischemia-reperfusion group,the expression of IL-10 was increased,while the expression of TNF-α was decreased significantly in PNS treatment group,behavior score of PNS treatment group increased significantly than that of ischemia-reperfusion group.Conclusion The panax notoginseng saponins can reduce the neurons injury after focal cerebral ischemia-reperfusion injury in rats partly by regulating the expression of IL-10 and TNF-α in the brain.